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FDA General

FDA APPROVED phentermine and topiramate extended-release capsules (Qsymia) over a photo of a teen girl on a scale.

<乌鸦传媒>FDA Expands Use of Weight-Loss Drug to Adolescents

Qsymia now approved for teens with obesity, along with diet and exercise

A photo of an opened blister pack of Paxlovid with the packaging in the background.

<乌鸦传媒>Should Young and Healthy Patients Take Paxlovid?

The antiviral has not been shown to be valuable in this population

A photo of a bottle of Rubraca tablets.

<乌鸦传媒>Drugmaker Pulls Third-Line PARP Inhibitor Approval in Ovarian Cancer

Decision on rucaparib follows negative OS signal and "discussions" with FDA

FDA APPROVED risankizumab (Skyrizi) over a computer rendering of Crohn鈥檚 disease.

<乌鸦传媒>FDA OKs Risankizumab for Crohn's Disease

Approval marks the third indication for the IL-23 inhibitor in adults

FDA EUA mRNA COVID-19 vaccines for children as young as 6 months over a photo of a baby getting vaccinated.

<乌鸦传媒>FDA Allows mRNA COVID Vaccines in Kids 6 Months and Up

Vaccines expected to protect against most severe outcomes, says FDA Commissioner

FDA APPROVED baricitinib (Olumiant) over a photo of a man with bald patches due to alopecia areata

<乌鸦传媒>FDA Approves First Systemic Treatment for Alopecia Areata

Four to 10 times as many patients met hair-regrowth endpoint with JAK inhibitor versus placebo

A computer rendering of a blue double helix with a yellow section.

<乌鸦传媒>FDA Panel Backs Gene Tx for Degenerative Brain Disorder in Kids

Advisers unanimously recommend approval for pediatric ALD patients without HLA-matched donors

A photo of a woman holding a bottle of vitamin gummies in front of a shelf of dietary supplements in a pharmacy.

<乌鸦传媒>It's High Noon for Dietary Supplements

The user fee legislation in Congress proposes useful regulations, but doesn't go far enough

A photo of a bottle of Ukoniq tablets.

<乌鸦传媒>FDA Pulls Lymphoma Approvals for PI3K Inhibitor Umbralisib

Worse overall survival observed despite improvements in progression-free survival

A photo of the Abbott Laboratories facility in Sturgis, Michigan.

<乌鸦传媒>Abbott Formula Plant Was 'Unacceptably Insanitary,' FDA Chief Tells Lawmakers

Abbott official says the company is "deeply, deeply sorry" about the formula shortage

FDA APPROVED tapinarof cream 1% (Vtama) over a photo of a woman applying lotion to the psoriasis on her forearm.

<乌鸦传媒>FDA OKs First Novel Nonsteroidal Topical for Plaque Psoriasis in 25 Years

Complete, near-complete clearance in 35-40% of patients treated with tapinarof cream 1%

FDA APPROVED Dupilumab (Dupixent) over an endoscopy of eosinophilic esophagitis

<乌鸦传媒>First Treatment Approved for Eosinophilic Esophagitis

FDA expands dupilumab's label to treat inflammatory condition

A photo of three bottles of Fluvoxamine Maleate tablets.

<乌鸦传媒>FDA Rejects Cheap Antidepressant to Treat Early COVID

David Boulware, who submitted the EUA for fluvoxamine, argues the agency is "behind the times"

FDA APPROVED tirzepatide (Mounjaro) over a photo of a bowl of sugar, sugar cubes, and a glucose monitor.

<乌鸦传媒>First GLP-1/GIP Receptor Agonist OK'd for Type 2 Diabetes

Injectable tirzepatide lands approval as an adjunct to diet and exercise

ACOG over a photo of Hilton Sandestin Beach Golf Resort & Spa in Miramar Beach, FL

<乌鸦传媒>Restrictions on Mifepristone a Barrier to Miscarriage Care, Surveys Show

Over a third of respondents do not prescribe the drug for early pregnancy loss, despite efficacy

FDA APPROVED Lumipulse G 尾-Amyloid Ratio (1-42/1-40) test over a computer rendering of amyloid plaques around neurons.

<乌鸦传媒>Early Alzheimer's Test Gets FDA Nod

First in vitro diagnostic to detect amyloid in early disease setting

FDA APPROVED Dual + Triple Pak of Voquezna over a computer rendering of H. pylori bacteria on the stomach lining.

<乌鸦传媒>Two New Regimens Win FDA Approval for H. Pylori Infection

Dual and triple vonoprazan-based treatments offer physicians another set of options

A photo of Polar mint flavored snus packets and container in a man鈥檚 hand.

<乌鸦传媒>How Far Should the Menthol Ban Go?

It's time to ban menthol in cigarettes -- but not necessarily in all tobacco products

FDA APPROVED viloxazine extended-release capsules (Qelbree) over a photo illustration of a confused man

<乌鸦传媒>FDA OKs New Nonstimulant Option for Adult ADHD

New selective norepinephrine reuptake inhibitor is no longer just for kids

A photo of a flattened empty package of Newport menthol cigarettes on asphalt.

<乌鸦传媒>FDA Proposes Ban on Menthol Cigarettes

"Long-awaited action" should reduce youth smoking, health disparities

FDA APPROVED oteseconazole (VIVJOA) over a computer rendering of candida auris bacteria and the female reproductive system.

<乌鸦传媒>FDA Approves First Drug for Recurrent Yeast Infections

Vivjoa indicated for infertile or postmenopausal women

<乌鸦传媒>FDA Issues Warning on Prenatal Genetic Tests

Relying on results could lead to inappropriate medical decisions, agency warns

FDA APPROVED sirolimus topical gel (Hyftor) over a photo of a drop of lotion on a woman鈥檚 finger tip.

<乌鸦传媒>First Topical Therapy for Facial Angiofibroma Nabs FDA Approval

New alternative to dermabrasion, laser treatment, surgery

FDA ADCOMM sodium phenylbutyrate + taurursodiol (AMX0035) over a computer rendering of a disintegrating motor neuron.

<乌鸦传媒>ALS Drug Needs More Evidence, FDA Advisors Say

But vote was close and panelists remain hopeful about AMX0035

FDA APPROVED testosterone undecanoate (TLANDO) over a man holding a white pill between his fingers and a glass of water.

<乌鸦传媒>Another Oral Testosterone Undecanoate OK'd for Hypogonadism

FDA approval of Tlando follows in the footsteps of Jatenzo

FDA APPROVED nivolumab and relatlimab-rmbw (Opdualag) over a computer rendering of a skin cross-section with melanoma.

<乌鸦传媒>Novel Fixed-Dose Immunotherapy Combo Wins FDA Approval

Nivolumab plus relatlimab doubled progression-free survival in unresectable melanoma

Blue rubber gloved hands holding a vial of umbilical cord stem cells.

<乌鸦传媒>Medicare Claws Back Money for Dubious Birth-Tissue Stem Cell Shots

Government seeks to recoup more than 2 years of payments for unproven treatments

A photo of Lucy McBride, MD

<乌鸦传媒>Meet the Primary Care Doc Who Wants the World to Go Back to Normal

Lucy McBride, MD, has become a loud, controversial voice in the debate on COVID precautions

FDA APPROVED Generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol with woman using inhaler.

<乌鸦传媒>First Generic OK'd for Popular Asthma, COPD Inhaler

FDA approves Mylan's Symbicort copy, reflecting agency's commitment to "increase competition"

FDA WARNING Renuvion/J-Plasma Device over photos of the device.

<乌鸦传媒>FDA Warns on Using Surgical Device for Aesthetic Skin Procedures

Agency details potentially life-threatening adverse events with plasma-generating device

FDA APPROVED olaparib (Lynparza) over a computer rendering of a tumor in a woman鈥檚 transparent breast

<乌鸦传媒>FDA OKs PARP Inhibitor as Adjuvant Therapy in Early Breast Cancer

Olaparib (Lynparza) approved for high-risk patients with germline BRCA mutations

A computer rendering of a man in a suit looking at a document while standing on top of and surrounded by tall stacks of paper

<乌鸦传媒>FDA Begins Releasing Pfizer COVID Vax Documents

Court-ordered release runs risk of "cherry picking and taking things out of context"

A photo of a bottle of Dr. Bronner鈥檚 Pure-Castile Soap next to a bath scrubber.

<乌鸦传媒>Dr. Bronner's Offering Its Workers Psychedelic Therapy Coverage

Soap company to cover ketamine-assisted therapy for employees with new industry nonprofit

A photo of a nurse's blue rubber gloved hand touching an IV drip bag in a hospital room

<乌鸦传媒>Thumbs Down for IV Tramadol, FDA Advisers Say

Delayed onset of pain relief remains a concern

A hand holding Senseonics continuous glucose monitor Eversense.

<乌鸦传媒>FDA OKs 180-Day Implantable Continuous Glucose Monitor

Senseonics' Eversense E3 System approved for adults with diabetes

FDA SAFETY enteral feeding tubes over a photo of enteral feeding tubing, syringes, and jars of formula.

<乌鸦传媒>FDA Warns of Strangulation Risk for Kids on Feeding Tubes

Two toddlers died after being found with enteral feeding systems' tubing around their necks

FDA SAFETY over a photo of a bottle of Ukoniq tablets.

<乌鸦传媒>FDA Concerned About Safety of Lymphoma Drug

Hint of excess mortality in trial of umbralisib/ublituximab prompts public notice

FDA APPROVED cyclosporine ophthalmic emulsion (Restasis) generic over a photo of a woman using eye drops

<乌鸦传媒>FDA Approves First Generic of Restasis for Dry Eye

A new option for those affected by keratoconjunctivitis sicca

FDA APPROVED Moderna COVID vaccine (Spikevax) over a photo of a vial of Spikevax

<乌鸦传媒>Another COVID Vaccine Garners Full FDA Approval

Moderna's Spikevax approved for adults ages 18 and up

A female physician fits a blood pressure cuff onto the arm of a man with down syndrome

<乌鸦传媒>Are We Equipped to Care for People With Intellectual, Developmental Disabilities?

Low accreditation standards are contributing to health disparities

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